Adjustable suture-button construct for ankle syndesmosis repair

ABSTRACT

An adjustable, knotless button/loop construct for fixation of ankle syndesmosis tibio-fibular diastasis and an associated method of ankle repair using the same. The knotless construct comprises a pair of buttons attached to a flexible, continuous, self-cinching, adjustable loop integrated with two splices that are interconnected. The knotless construct is passed through fibular and tibia tunnels and the buttons are secured on the cortical surfaces of tibia and fibula. One of the buttons (for example, an oblong button) is secured on the medial side of the tibia by passing the button and the flexible, adjustable loop though the fibular and tibia tunnels and then flipping and seating the button outside the tibia. The length of the flexible adjustable loop is adjusted so that the second button (for example, a round button) is appropriately secured on the lateral fibula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/414,706, filed Nov. 17, 2010, the entire disclosure of which isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to the field of ankle surgery and, moreparticularly, to ankle syndesmosis repair techniques and associatedfixation and reconstruction devices.

BACKGROUND OF THE INVENTION

Ankle injuries are among the most common of the bone and joint injuries.The ankle joint is formed of three bones coming together: the tibiawhich makes up the medial, or inside, anklebone; the fibula whichparallels the tibia and makes up the lateral, or outside, anklebone; andthe talus. The far ends of the tibia and fibula are known as themalleoli and together they form an arch that sits on top of the talus.

A fibrous membrane (the joint capsule) encases the joint architectureand is lined with a smoother layer called the synovium. The jointcapsule contains the synovial fluid produced by the synovium. Thesynovial fluid allows for smooth movement of the joint surfaces. Theankle joint is stabilized by three groups of ligaments, which are fibersthat hold these bones in place.

Surgery to fix an ankle fracture is indicated for patients who suffer adisplaced ankle fracture involving the bone on the inside to the ankle(tibia), the bone on the outside of the ankle (fibula), or both. Oneinjury that may occur in the ankle is a disruption of the syndesmosis. Asyndesmostic injury is a disruption of the strong fibrous ligaments thathold the fibula and tibia together near the ankle joint. If thesyndesmosis is disrupted, then the ankle joint will be unstable andsurgery is usually indicated.

A suture-button construct for ankle syndesmosis repair is the subjectmatter of U.S. Pat. No. 7,235,091, the disclosure of which isincorporated by reference herein in its entirety. The construct andtechnique disclosed in this prior patent greatly facilitates anklesyndesmosis repair as compared to the prior art, but it requires thetying of knots to secure the second (round) button against the surfaceof the lateral fibular cortex. An ankle syndesmosis repair construct andtechnique is needed which provides the same fixation as disclosed in theaforementioned patent, but without the need for tying knots.

SUMMARY OF THE INVENTION

The present invention provides methods and reconstruction systems (anadjustable, self-locking knotless button/loop construct) for anklesyndesmosis with or without associated ankle fractures repair. Oneembodiment system of the present invention comprises an adjustable,knotless button/loop construct formed of a pair of fixation devices (forexample, two buttons) connected by an adjustable, knotless flexibleloop. Another embodiment system of the present invention comprises anadjustable, knotless button/loop construct interlocked with anon-adjustable loop each attached to a fixation device (for example, twobuttons. The loop includes a flexible material (preferably suture orsuture tape), for fracture fixation when a plate is disposed between thefractured bone and one fixation device.

The present invention also provides a method of assembling an adjustableself-locking, knotless button/loop construct by inter alia: (i)providing two fixation devices (i.e., an oblong button and a roundbutton); (ii) threading a flexible strand through holes of the first andsecond button, to form a braid loop and an intertwining or interlinking“x” of the braid on the round button; (iii) forming two adjustableeyesplices on the braid loop and through the oblong button, so that theoblong button is centered between the two spliced sections; and (iv)threading the tails through the top holes of the round button.

The present invention also provides a method of ankle syndesmosis repairby inter alia: (i) providing an ankle repair system comprising anadjustable, self-locking knotless button/loop construct including twofixation devices (for example, a round button and an oblong button), andat least one flexible, adjustable loop attached to the fixation devices(i.e., the buttons); and (ii) securing the repair system to misalignedbones of the ankle.

The present invention also provides a method of ankle syndesmosis repairby inter alia: (i) providing an ankle repair system comprising anadjustable, self-locking knotless button/loop construct including twofixation devices (for example, a round button and an oblong button), andat least one flexible, adjustable loop attached to one fixation devices(i.e., the buttons) and a non-adjustable loop connected to the secondfixation device; and (ii) securing the repair system to misaligned bonesof the ankle.

The present invention also provides a fracture management system byinter alia: (i) providing an ankle repair system comprising anadjustable, self-locking knotless button/loop construct including twofixation devices (for example, a round button and an oblong button), andat least one flexible, adjustable loop attached to the fixation devices(i.e., the buttons); (ii) providing a fracture plate, and (iii) securingthe repair system and plate to misaligned and fractured bones of theankle.

These and other features and advantages of the present invention willbecome apparent from the following description of the invention that isprovided in connection with the accompanying drawings and illustratedembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrates a schematic top view of a round button andan oblong (elongated) button of an adjustable, self-locking knotlessbutton/loop construct of the present invention.

FIG. 2 illustrates the braid strand passed through holes 1 and 2 of theround button of FIG. 1A.

FIG. 3 illustrates the braided strand passed through the eyelet holes ofthe oblong button of FIG. 1B.

FIG. 4 illustrates the strand passed through hole 3 of the round button.

FIG. 5 illustrates the braid loop connecting the round button and theoblong button.

FIG. 6 illustrates the strand from hole 3 passing under the strandbridging holes 1 and 2.

FIGS. 7A and 7B illustrate the intertwined strands forming an “X” on theround button.

FIG. 8 illustrates the tail strands of each side of the round buttonpulled towards the oblong button.

FIG. 9 illustrates the tail strands exiting from holes adjacent to oneanother on the round button and strands forming a loop through theoblong button exiting from holes adjacent to one another on the roundbutton.

FIG. 10 illustrates an enlarged view of the underside of the roundbutton.

FIG. 11 illustrates an enlarged view of the 0.75″ splice (with theoblong button moved to the side to allow splicing near the center of thebraided loop formed between the buttons).

FIG. 12 illustrates a splice on one side with tail passing through theoblong button.

FIG. 13 illustrates the formation of a second splice with the strandexiting at the end of the first splice.

FIG. 14 illustrates the strands passing through top holes 1 and 3 of theround button.

FIG. 15 illustrates the final construct (adjustable, self-lockingknotless button/loop construct) of the present invention.

FIG. 16 is another, schematic view of the final, assembled,self-locking, knotless button/loop construct of the present invention(with a knotless, self-locking, loop attached to a round button and anoblong button, and with two splices through the oblong button, andintertwining/crossing strands on the round button).

FIGS. 17-20 illustrate subsequent steps of a method of ankle syndesmosisrepair employing the self-locking, knotless button/loop construct ofFIG. 16 and according to the present invention.

FIG. 21 illustrate a fracture fixation plate with self-locking, knotlessbutton/loop construct of FIG. 16.

FIGS. 22-26 illustrate subsequent steps of a method of ankle syndesmosisrepair and fracture fixation employing the self-locking, knotlessbutton/loop construct of FIG. 16 and the fixation plate of FIG. 21.

FIG. 27 illustrate a buttress plate with self-locking, knotlessbutton/loop construct of FIG. 16.

FIGS. 28-29 illustrate subsequent steps of a method of ankle syndesmosisrepair employing the self-locking, knotless button/loop construct ofFIG. 16 and the buttress plate of FIG. 27, of the present invention.

FIG. 30-32 respectively locking straight, tubular and hooking plateswith self-locking, knotless button/loop construct of FIG. 16.

FIG. 33 schematically. illustrates another adjustable loop construct inaccordance with the present invention.

FIG. 34 schematically illustrates a further adjustable loop construct inaccordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides assembling steps and reconstructionsystems for the stabilization of ankle bones (for ankle syndesmosisrepair) using an adjustable, knotless button/loop construct in aminimally invasive approach.

The stabilization system of the present invention comprises a knotlessbutton/loop construct including two fixation devices (for example, twobuttons) and at least one flexible, adjustable loop attached to the twofixation devices (i.e., the buttons). The knotless button/loop constructhas an adjustable loop length and allows adjustment in one directionwhile preventing or locking the construct from loosening in the oppositedirection, due to applied tensile forces.

The present invention also provides a method of ankle repair by interalia: (i) providing a button/loop construct with two buttons and atleast one flexible, adjustable loop (a four-point knotless fixationdevice) that is capable of adjusting tension (i.e., is provided with aloop having an adjustable perimeter and length) attached to the buttons;and (ii) securing the ankle bones in the proper position by advancingthe button/loop construct through tunnels formed within the ankle bones.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIG. 1 illustrates top views of two fixationdevices 10, 20 (button 10, 20) used for assembling the knotless,integrated, ankle repair system 100 (button/loop construct 100) of thepresent invention (shown in FIGS. 15 and 16). The knotless repair system100 is an integrated system comprising two fixation devices 10, 20attached to at least one flexible, adjustable loop formed of a flexiblematerial 30.

The flexible material 30 forming the loop has an adjustable length and,as described below, is connected to two fixation devices (buttons) thatare further secured on tibial cortex and fibular cortex, respectively.The flexible material is threaded through apertures/holes/eyelets ofeach of the first and second fixation devices 10, 20 and splices arecreated to form the knotless, integrated, self-cinching ankle repairsystem 100. In an exemplary only embodiment, and as detailed below, theflexible material 30 may be suture such as a suture braid with braidedfilaments having a hollow core (for example, strands of suture such asultrahigh molecular weight polyethylene (UHMWPE) braided with strands ofpolyester, collagen, or other suture materials, such as PET, PEEK, silknylon, and absorbable polymers, among many others).

In an alternative embodiment, the flexible material 30 may be suturesuch as FiberWire®, e.g., UHMWPE and polyester braided over a core ofUHMWPE, such as #2 FiberWire®.

In an exemplary embodiment only, the first fixation device 10 is a roundbutton provided with four circular holes having a round configuration,and the second fixation device 20 is an oblong button provided with twoeyelets 5 and 6 having an oblong or elliptical configuration, or anyother configuration including round, teardrop shape, or circularconfiguration. Although the embodiments below will be detailed withreference to particular configurations for the first and second fixationdevices 10, 20 (i.e., a round button and an oblong, elongate button),the invention is not limited to this exemplary embodiment only and hasapplicability to fixation devices with other shapes and geometries, aslong as the fixation devices are provided with apertures/holes/passagesthat allow a flexible material (a flexible strand) to pass therethrough(or be threaded therethrough) to form the flexible, adjustable,self-cinching, knotless loop of the invention.

FIGS. 2-14 illustrate exemplary steps of a method of assembling thereconstruction system 100 of FIGS. 15 and 16 (with the followingstarting materials which are only exemplary).

Starting Materials:

Braided high strength (UHMWPE) suture strand 30

Needle with nitinol loop 41

Round button 10

Oblong button 20

Assembly Instructions:

Step 1: A braided strand 30 is inserted through holes 1 and 2 of theround button 10. Fold braid 30 at midpoint to create two parallel equallength strands. FIG. 1 shows the braided strand 30 through holes 1 and 2of the round button 10. In an exemplary embodiment, braided strand 30 isa braided UHMWPE strand.

Step 2: One end of the braided strand 30 is inserted through botheyelets 1 and 2 of the oblong button 20. FIG. 3 shows the braided strand30 through the eyelets 5 and 6.

Step 3: The same strand 30 (that passed through oblong button 20) isthreaded through hole 3 of the round button 10. This creates a loop 31(FIG. 5) connecting both buttons 10, 20. FIG. 4 shows the strand 30through hole 3 of the round button 10, and FIG. 5 shows the braid loop31 connecting the round button 10 and the oblong button 20.

Step 4: The tail of the same strand 30 (that passed through hole 3) ispassed under the strand looped through holes 1 and 2. FIG. 6 shows thestrand from hole 3 passing under the strand in holes 5 and 6 of theround button 10. The tail of the same strand 30 is then passed over thestrand looped through holes 1 and 2.

Step 5: The tail of same strand 30 is then threaded down through hole 4.This forms an intertwining or interlinking “X” 35 of the braid 30. Thestrand looped across holes 1 and 2 will be linked with the strand acrossholes 3 and 4. FIG. 7A and its schematic representation of FIG. 7B showthe intertwined strands forming an “X” structure 35 on the round button10.

Step 6: The following is confirmed:

-   a) The tails of each strand are pulled towards the oblong button 20    on each side of the round button 10 (as shown in FIG. 8).-   b) Viewing the underside of the round button 10, the tail strands    are exiting from holes adjacent to one another (as shown in FIGS. 9    and 10).-   c) Viewing the underside of the round button 10, the strands forming    the loop 31 through the oblong button 20 are adjacent to one another    (as shown in FIGS. 9 and 10).

FIG. 8 shows the tail strands of each side of the round button 10 pulledtowards the oblong button 20. FIG. 9 shows the tail strands exiting fromholes adjacent to one another on the round button 10 and strands formingloop 31 through the oblong button 20 exiting from holes adjacent to oneanother on the round button 10. FIG. 10 shows the close up view of theunderside of the round button 10.

Step 7: One tail strand is used to start a splice towards the midpointof the braid loop 31 at oblong button 20. A splice 44 a (FIG. 12) iscreated by passing the blunt tip needle 41 through the center of thebraid 30 with the end of the strand 30 being carried through in thenitinol loop of the needle 41. The oblong button 20 may need to be movedto the side to allow splicing. The splice location should preferably beon the same side as the tail strand making the splice. FIG. 11 shows aclose up of splice 44 a. The oblong button 20 is moved to the side toallow splicing near center of braided loop 31 formed between buttons 10,20.

Step 8: After the strand 30 is carried with needle 41 to create thesplice 44 a, the tail of the strand is threaded through both eyeletholes in the oblong button 20 (in from the bottom and out the top of thebutton 20). The oblong button 20 is slid so that it rests over splicedsection. FIG. 12 shows the splice 44 a on one side with the tail passingthrough the oblong button 20.

Step 9: Steps 7 and 8 (detailed above) are repeated to create anothersplice 44 b with the opposing strand on the other side. The secondsplice 44 b should be created such that the exiting aperture of thesplice is as close as possible to the first splice 44 a. The splicelength may be about 17-19 mm. The tail of the strand is threaded throughboth eyelet holes of oblong button 20. FIG. 13 shows the formation ofsecond splice 44 b with the strand exiting at end of first splice 44 aand as part of knotless, adjustable flexible loop 33.

Step 10: The oblong button 20 is slid to center between the two splicedsections 44 a, 44 b. The oblong button 20 sits approximately centeredbetween the splices. The lower round button 10 sits approximatelycentered between intertwining/crossing “X” 35 of the strands.

Step 11: The tails of each strand are threaded through the top holes(holes 1 and 3) in the round button 10. Care should be taken to threadthe tails through holes on same side of the button 10. Strands shouldnot be crossed or twisted. The result is one overall adjustable knotlessloop 33. FIG. 14 shows the strands passing through top holes 1 and 3 ofthe round button 10.

Step 12: After the button/loop construct 100 is constructed, theconstruct is stretched. The force to stretch the loop of the constructis applied such that it acts on the overall loop created between the twosplices 44 a, 44 b rather than on individual splice loop.

FIGS. 15 and 16 show the final construct 100. As shown in FIGS. 15 and16 and as detailed above, button/loop construct 100 (reconstructionsystem 100) is formed of a pair of buttons 10, 20 connected by aflexible, knotless, adjustable loop 33. Loop 33 includes a flexiblematerial 30 with two adjustable eyesplices 44 a, 44 b.

In an exemplary and illustrative embodiment only, self-locking,knotless, adjustable button/loop construct 100 includes buttons 10, 20and flexible material 30 with two adjustable eyesplices 44 a, 44 b thatare interconnected to form one adjustable loop 33. By pulling on thefree braid strands 30, the individual eyesplices constrict and, in turn,reduce the loop length of loop 33. Elongation of loop 33 is preventedbecause for loop 33 to elongate, a force must be applied interior to oneor both of the eyesplices to elongate the individual loops.

Details regarding the formation/assembly of a self-locking adjustableconstruct with only one fixation device and two adjustable discretesplices, each splice (and which allows a graft to be fully inserted andseated in a bone tunnel) are provided in U.S. Patent ApplicationPublication Nos. 2010/0256677 and 2010/0268273, the disclosures of whichare incorporated by reference in their entirety herewith.

As described in the above-noted applications, a self-locking,adjustable, knotless construct includes a button and a flexible materialwith two adjustable eyesplices that are interconnected to form anadjustable continuous loop. By pulling on the free braid strands, theindividual eyesplices constrict and, in turn, reduce the loop length Lof loop. In order for the loop to elongate, a force needs to be appliedinterior to one or both of the eyesplices to elongate the individualloops.

Exemplary steps of a method of forming/assembling a self-lockingadjustable knotless construct with only one fixation device (i.e., withonly one button) and two splices/eyesplices are detailed in theabove-noted applications, and include as starting materials a suturestrand (for example, 50 inches of braided UHMWPE strand); a needle (forexample, a blunt tip needle with nitinol loop) and a button (forexample, a 3.5 mm titanium button). The suture strand is folded tocreate two equal length parallel braid strands. At this step, the braidis folded at the midpoint, 25 inches, to create two parallel equallength braid strands (Step 1). At Step 2, a first eyesplice is createdon the first strand of braid by passing the blunt tip needle through thecenter of the braid with the end of the braid being carried through inthe nitinol loop of the needle. The splice should travel for a distanceof about 17-19 mm through the braid towards the braid midpoint createdin Step 1.

Once the first eyesplice has been formed, at Step 3, the button is slidover the non-spliced strand passing the strand through both buttonholes. The button is slid so that it rests over the first splicedsection. At Step 4, a second eyesplice is formed, similar to the firstone, with the opposing strand. The strand should be looped through thefirst eyesplice loop resulting in two eyesplice loops that areinterconnected. Again, the splice length should be between 17-19 mm. Thesplice should be created such that the exiting aperture of the splice isas close as possible to the first eyesplice.

Buttons 10, 20 of the construct 100 of the present invention may beformed, for example, of metal, PEEK or PLLA. As detailed above, thebuttons are provided with openings (apertures, eyelets, holes) thatallow the passage of the flexible material 30 to pass thereto.

The flexible material 30 is preferably a braided high strength suturematerial. The flexible material 30 may be provided with optional coloredstrands to assist surgeons in distinguishing between suture lengths withthe trace and suture lengths without the trace. The flexible material 30may be also provided in the form of a suture tape, or a combination ofsuture strand and suture tape, and as desired. The flexible material 30may be suture such as a suture braid with braided filaments having ahollow core (for example, strands of suture such as ultrahigh molecularweight polyethylene (UHMWPE) braided with strands of polyester,collagen, or other suture materials, such as PET, PEEK, silk nylon, andabsorbable polymers, among many others). The flexible material 30 mayalso contain a bioabsorbable material, such as PLLA, one of the otherpolylactides, or collagen, for example, and/or may be formed of twistedfibers having strands of a contrasting color added to the braidedthreads, to make the suture more visible during surgical procedures. Inexemplary embodiments, flexible material 30 may be a braided suturecover containing strands of a high strength suture material, such asFiberWire™ suture, sold by Arthrex, Inc. of Naples, Fla. The tail endsmay preferably be coated (for example, tipped with Loctite or otheradhesive).

The method of ankle syndesmosis repair using the suture-button constructof the present invention is similar to that disclosed in U.S. Pat. No.7,235,091, except that, advantageously, no knot tying is required.Instead, the first (oblong) button of the construct is passed (with asuture passing instrument such as a needle) through drill holes passingthrough the fibula and tibia bones, flipped and secured against themedial tibial cortex, and the second (round) button is then tightenedagainst the lateral fibular cortex simply by cinching the adjustableconstruct (instead of tying knots).

FIGS. 17-20 illustrate ankle repair system 100 of the present inventionemployed in a method of ankle repair (fracture fixation and/orsyndesmosis reduction) according to the present invention. A drill hole88 is formed through tibia 90 and fibula 80. A long straight needle 85with pull-through sutures 86 and optionally 87, are attached to therepair system 100 and passed through the drill hole 88, to advance thefirst, leading oblong button 20 substantially horizontally through thedrill hole 88, as shown in FIGS. 18 and 19. Slight upward tension shouldbe placed on the white pull-through suture, while placing downwardtension on the green/white suture. The button should seat easily alongthe medial cortex. Once the first, oblong button 20 has exited themedial tibia 90, the angle of traction on the pull-through suture 86, 87is changed and counter-traction is exerted on the loop 33, in order toflip (pivot) and engage the oblong button 20 against the medial tibialcortex (FIG. 20).

Once the oblong button 20 is anchored, the pull-through suture 88 can becut and removed. The trailing or second, round button 10 is tighteneddown on the lateral side by further traction on the free ends of thesuture 30 to tightened the adjustable, flexible loop 33 and adjust thetension between the two buttons 10, 20 (FIG. 20). This will furthersqueeze the syndesmosis but will not over-tighten it.

FIGS. 21, 27 and 30-32 illustrate fixation or buttress plates using thereconstruction system 100, whereas FIGS. 22-26 and 28-29 illustrateassembly steps for attaching reconstruction system 100, after a fractureplate 200, 400, 500, 600 or buttress plate 300 is affixed. FIGS. 22-26illustrate, drilling all four cortices, 1.5 cm above the ankle joint, inthe transmalleolar plane (30° anterior to the coronal plane), using the3.5 mm Drill Bit. The needle and pull-through sutures 86, 87 are passedalong the drill hole and out the intact medial skin. The white 2-0FiberWire pull-through suture advances the button 20, until it justexits the medial tibial cortex. A number 2.0 FiberWire suture may beadded to facilitate placement of button 20. The pull-through sutures arecut where they connect to the needle after passage through the medialskin. The button 20 should seat easily along the medial.

FIGS. 28-29 illustrate attachment of construct 100 of the presentinvention may with a buttress plate 300 that features a four-hole plate.The contoured, titanium plate is preferably used as a “buttress” forankle syndesmotic repairs with or without ankle fracture. The plate hastwo inner holes that custom fit the button 10, and two outer holes thataccept two 3.5 mm×14 mm non-locking screws. The 3.5 mm screws are placedin the proximal and distal holes of the plate and the construct 100 isthen placed in either the third hole (6), or both central holes (inset),if desired.

FIGS. 33 and 34 schematically illustrate alternative attachmentconstruct embodiments where loop 31 of construct 100 interlocked with anon-adjustable loop 131 of flexible material. The construct embodimentof FIG. 33 is deployed in a manner similar to that illustrated in FIGS.17-20 when a plate is not needed or used, and FIGS. 22-29 when a plateis used as detailed above. In the construct embodiment of FIG. 34, a4-hole button 120 is used and the suture, after passing from eyesplices44 a and 44 b is threaded through the holes in button 20 and though the3rd and 4th holes in button 120.

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is not to be considered as limited by theforegoing description.

1. An adjustable button/loop construct, comprising: a first fixationdevice with a first configuration, a second fixation device with asecond configuration, and a flexible, continuous loop connected to thefirst and second fixation devices, the flexible, continuous loop havingan adjustable length and two adjustable eyesplices that areinterconnected.
 2. The construct of claim 1, wherein the first andsecond fixation devices are a round button and an oblong button.
 3. Theconstruct of claim 1, wherein the first fixation device is an oblongbutton with an oblong body defining two eyelets, and the second fixationdevice is a round button with a round body defining four apertures. 4.The construct of claim 3, wherein a flexible strand is mounted in usebetween the oblong and round buttons so that the flexible strand is fedthrough first and second apertures of the round button and then throughboth eyelets of the oblong button, and then through a third aperture ofthe round button and under the flexible strand looped through the firstand second apertures, and then down through a fourth aperture of theround button.
 5. The construct of claim 1, wherein the adjustable loopis formed of a high strength suture.
 6. The construct of claim 1,wherein the adjustable loop is formed of a braided material.
 7. Theconstruct of claim 1, wherein the two adjustable eyesplices are formedof a high strength suture.
 8. An apparatus comprising a kit of partscomprising: first and second buttons each having at least first andsecond apertures; a flexible coupling mounted, in use, between the firstand second buttons, wherein the flexible coupling includes anadjustable, closed, flexible, knotless loop having an adjustable lengthand two adjustable eyesplices that are interconnected; and a needlesecured to one of the first and second buttons by a suture, the suturebeing looped through one of the at least first and second apertures. 9.The apparatus of claim 8, wherein one of the first and second buttons isan oblong button and the other of the first and second buttons is around button.
 10. The apparatus of claim 8, wherein the adjustableclosed, flexible, knotless loop is formed of a braided material.
 11. Theapparatus of claim 8, wherein the adjustable loop is formed by the stepsof: providing a flexible strand having two ends; passing the flexiblestrand through first and second holes of the first button; passing theflexible strand through eyelets of the second button; passing theflexible strand through a third hole of the first button, to connect thefirst button to the second button; passing the flexible strand from thethird hole under a strand from first and second holes, and through afourth hole of the first button, to form an adjustable, flexible loop;forming a first eyesplice by passing a needle attached to the flexiblestrand through the flexible strand and near a center of the loop formedbetween the two buttons; and forming a second eyesplice by passing theneedle through the flexible strand and near the first eyesplice.
 12. Anadjustable construct for ankle syndesmosis repair using tibia and fibulatunnels, comprising: a round button and an elongate button; and acontinuous loop of flexible material attached to the round and elongatebuttons, wherein the continuous loop has an adjustable length to allowpositioning of the ankle construct within the tibia and fibula tunnels,and wherein the continuous loop is provided with two splices that allowadjustment in one direction while locking the ankle construct in theopposite direction.
 13. The ankle construct of claim 12, wherein theelongate button is adapted for engagement on tibial cortex and whereinthe round button is adapted for engagement on fibular cortex, andwherein the continuous loop extends through the tibia and fibulatunnels.
 14. The ankle construct of claim 12, wherein the loop has alength which is about equal to a length of the tibia tunnel, the fibulatunnel and of an distance between the tibia tunnel and the fibulatunnel.
 15. A method of fixation of ankle syndesmosis tibio-fibulardiastasis, comprising the steps of: providing a construct comprising anadjustable button/loop construct having two buttons and a flexible,adjustable loop connected to the two buttons, the flexible loop havingan adjustable length and two splices that are interconnected, theflexible loop being connected to the two buttons; inserting theconstruct within a hole through fibula and within a hole through tibia,and out of medial skin; and adjusting the length of the loop to secureone of the two buttons against the medial tibia and the other of the twobuttons against the lateral fibula.
 16. The method of claim 15, furthercomprising the steps of: advancing a first of the two buttons and theadjustable button/loop through the hole through fibula and the holethrough tibia, so as the first button exits the tibia and pivots andengages a cortical surface of the tibia; and adjusting the length of theloop to position the adjustable button/loop within the hole throughfibula and the hole through tibia.
 17. The method of claim 15, whereinthe construct is formed by the steps of: providing a flexible strandhaving two ends; passing the flexible strand through first and secondholes of a first button; passing the flexible strand through eyelets ofa second button; passing the flexible strand through a third hole of thefirst button, to connect the first button to the second button; passingthe flexible strand from the third hole under a strand from first andsecond holes, and through a fourth hole of the first button, to form anadjustable, flexible loop; forming a first splice by passing a needleattached to the flexible strand through the flexible strand and near acenter of the loop formed between the two buttons; and forming a secondsplice by passing the needle through the flexible strand and near thefirst splice.
 18. The method of claim 15, wherein the one of the twobuttons has a configuration which is different from a configuration ofthe other one of the two buttons.
 19. A method of ankle reconstruction,comprising: providing a construct comprising a first fixation deviceconnected to a second fixation device by a continuous loop of flexiblematerial attached to the first and second fixation devices, the loop offlexible material having an adjustable length and being provided withtwo splices that are interconnected; inserting the construct within afibula tunnel and a tibia tunnel by advancing the first fixation devicethrough the fibula and tibia tunnels so as to exit tibia and to pivotand engage a cortical surface of the tibia; and adjusting the length ofthe continuous loop, to fixate the construct within the fibula and tibiatunnels.
 20. The method of claim 19, wherein the first fixation deviceis a button with a circular body and circular apertures, and the secondfixation device is a button with an oblong body and oblong apertures,and wherein the loop is passed through all the circular apertures andall the oblong apertures.
 21. A fixation system comprising, a constructaccording to claim 1 and a fixation plate.
 22. A fixation systemaccording to claim 1, wherein a flexible member loop interconnects thecontinuous adjustable loop with one of the first and second fixationdevices